The role of knowledge and medical involvement in the context of informed consent: a course or a blessing?
Medicine, Health Care and Philosophy, 1 November 2022
Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often over-medicalized, that is to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context.
The “teach-back” method improves surgical informed consent and shared decision-making: a proof of concept study
Kevin D. Seely, Jordan A. Higgs, Lindsey Butts, Jason M. Roe, Colton B. Merrill, Isain Zapata, Andrew Nigh
Patient Safety in Surgery, 28 October 2022; 16(33)
The teach-back method is a communication tool that can improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on teach-back in surgical patient education and informed consent is limited, and few studies have been conducted to test its impact on perioperative patient interactions. The objective of this study was to evaluate if the teach-back method can improve informed consent and surgeon trust. An assessment of the time required to be implemented was also evaluated.
A standardized interaction role-playing a pre-operative informed consent discussion was designed. Laparoscopic cholecystectomy was selected as the proposed procedure. Standardized patients were split into two groups: teach-back and a control group. The control group was delivered a script that discloses the risks and benefits of laparoscopic cholecystectomy followed by a concluding prompt for any questions. The teach-back group was presented the same script followed by the teach-back method. Interactions were timed and patients completed a quiz assessing their knowledge of the risks and benefits and a survey assessing subjective perceptions about the interaction. Statistical analysis through Generalized Linear Models (GLMs) was used to compare visit length, performance on the comprehension quiz, and subjective surgeon trust perceptions.
34 participants completed the scenario, the comprehension quiz, and the survey (n = 34). Analysis of the subjective evaluation of the physician and encounter was significant for increased physician trust (p = 0.0457). The intervention group performed higher on the knowledge check by an average of one point when compared to the control group (p = 0.0479). The visits with intervention took an average of 2.45 min longer than the control group visits (p = 0.0014). People who had the actual procedure in the past (evaluated as a confounder) were not significantly more likely to display the same effect as the teach-back method, suggesting that the knowledge and trust gained were not based on previous experiences with the procedure.
When employed correctly by surgeons in the perioperative setting, the teach-back method enhances shared decision-making, comprehension, and surgeon trust. Incorporating the teach-back method into risk and benefit disclosures effectively informs and more fully engages patients in the informed consent process. Notably, the added benefits from using teach-back can be obtained without a burdensome increase in the length of visit.
Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent
N.Vartanian, M.Wilson, R.P.Ermoian
International Journal of Radiation Oncology*Biology*Physics, 1 November 2022; 114(3) pp e500-e501
Informed consent is an essential component of cancer care. The terms “second tumors” or “secondary tumors” are sometimes used in radiation therapy consent. Their incidences are sometimes described as “rare,” although vary greatly from nearly negligible in patients treated with palliative intent, to 20% in young patients undergoing myeloablative total body irradiation. We evaluated whether patients without prior knowledge of radiation therapy interpret the terms in a way consistent with physician intent.
We screened 164 adult subjects who did not require medical interpreters at a university-affiliated family medicine clinic, excluding cancer patients and those with any prior knowledge of or experience with radiation treatment. One hundred subjects were eligible for and completed a 12-question multiple choice questionnaire, which assessed their understanding of the term “secondary tumor” or “second tumor”, and how they would interpret the terms “small chance” or “rare” in the context of a “bad side effect.”
Twenty-nine percent of subjects correctly identified that “secondary tumors” referred to new and different tumors caused by treatment. Forty-nine percent thought the term referred to their original tumor recurring, and 22% thought the term referred to new and different tumors not caused by radiation therapy. Subjects with college degrees were not more likely to choose the correct answer than subjects without college degrees p=0.63. College degree status was not available for 5 subjects. Given choices between 1:10, 1:100, 1:1000, and 1:100,000, subjects associated “rare” with 1:1000 or 1:100,000 82% of the time. The term “small chance” was associated with 1:1000 or 1:100,000 59% of the time.
Adult non-cancer patients have a demonstrably different understanding than radiation oncologists of the terms “second tumor” or “secondary tumor.” Additionally, patient understanding of the terms “rare” or “small chance” varies from secondary malignancy incidences in many clinical scenarios. Radiation oncologists should use clearer terms for secondary malignancies and their incidence.
Survey of Informed Consent Procedures in Urology
Juliana Kim, Arnav Srivastava, Alexandra Tabakin, Eric A Singer
Journal of the American College of Surgeons, November 2022; 235(5)
The American Urological Association and American College of Surgeons codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. This study analyzes how these requirements are met by urology training programs.
An anonymous electronic survey was distributed to the program directors (PDs) of the 143 ACGME urology residency programs in the US in 2021. Responses were procured during 3 months. Information was collected regarding program demographics, aspects of the program’s consent process, and the disclosure of the role and participation of residents to patients.
Of 143 distributed surveys, 30.0% (n = 43) received a response. Of responding PDs, 67.4% reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25.1%), expected recovery time (22.8%), length of the surgery (22.2%), the people involved (18.0%), and their specific roles (7.2%). Of PDs, 48.8% and 87.8% of do not explicitly discuss trainee involvement or when a resident performs the majority of the case, respectively (Figure). Of PDs, 78.8% do not communicate medical student involvement. Of PDs, 73.2% reported having a patient decline participation of a trainee after describing their role.
Despite the American Urological Association and American College of Surgeons codes of professionalism, many urologists involved in the training of residents may not disclose resident participation in surgery to patients. Further discussions are needed to explore how to better balance resident education while strengthening the informed consent process.
How I Learned is How I Teach – Perspectives on How Faculty Surgeons Approach Informed Consent Education
Erin M. White, Andrew C. Esposito, Vadim Kurbatov, Xujun Wang, Michael G. Caty, Maxwell Laurans, Peter S. Yoo
Journal of Surgical Education, 15 October 2022
To understand the variability of surgical attending experience and perspectives regarding informed consent and how it impacts resident education
A novel survey was distributed electronically to explore faculty surgeon’s personal learning experience, knowledge, clinical practice, teaching preferences and beliefs regarding informed consent. Chi-square and Kruskal-Wallis testing was performed to look for associations and a cluster analysis was performed to elucidate additional patterns among.
Single, tertiary, university-affiliated health care system (Yale New Haven Health in Connecticut), including 6 teaching hospitals.
Clinical faculty within the Department of Surgery.
A total of 85 surgeons responded (49% response rate), representing 17 specialties, both private practice and university and/or hospital-employed, with a range of years in practice. Across all ages, specialties, the most common method for both learning (86%) and teaching (82%) informed consent was observation of the attending. Respondents who stated they learned by observing attendings were more likely to report that they teach by having trainees observe them (OR 8.5, 95% CI 1.3-56.5) and participants who recalled learning by having attendings observe them were more likely to observe their trainees (OR 4.1, 95% CI 1.5-11.2).Cluster analysis revealed 5 different attending phenotypes with significant heterogeneity between groups. A cluster of younger attendings reported the least diverse learning experience and high levels of concern for legal liability and resident competency. They engaged in few strategies for teaching residents. By comparison, the cluster that reported the most diverse learning experience also reported the richest diversity of teaching strategies to residents but rarely allowed residents to perform consent with their patients. Meanwhile, 2 other cluster provided a more balanced experience with some opportunities for practice with patients and some diversity of teaching– these clusters, respectively, consist of older, experienced general surgeons and surgeons in trauma and/or critical care.
Surgeon’s demographics, personal experiences, and specialty appear to significantly influence their teaching styles and the educational experience residents receive regarding informed consent.
Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists’ attitudes and practices in Germany
Leonie Gerke, Ann-Katrin Meyrose, Yvonne Nestoriuc
Clinical Psychology and Psychotherapy, 10 October 2022
This study aimed to assess clinicians’ attitudes and their current clinical practices regarding informed consent for psychotherapy.
A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey.
Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%).
Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision-making and might have a positive influence on treatment expectations and outcomes.
Subtotal Cholecystectomy Results in High Peri-operative Morbidity and Its Risk-Profile Should be Emphasised During Consent
Original Scientific Report
James Lucocq, David Hamilton, John Scollay, Pradeep Patil
World Journal of Surgery, 8 October 2022
Subtotal cholecystectomy aims to reduce the likelihood of bile duct injury but risks a multitude of less severe, yet significant complications. The primary aim of the present study was to report peri-operative outcomes of subtotal laparoscopic cholecystectomy (SLC) relative to total laparoscopic cholecystectomy (TLC) to inform the consent process.
All laparoscopic cholecystectomies between 2015 and 2020 in one health board were included. The peri-operative outcomes of SLC (n = 87) and TLC (n = 2650) were reported. Pre-operative variables were compared between the two groups to identify risk factors for SLC. The outcomes between the SLC and TLC were compared using univariate, multivariate and propensity analysis.
Risk factors for SLC included higher age, male gender, cholecystitis, increased biliary admissions, ERCP, cholecystostomy and emergency cholecystectomy. Following SLC, rates of post-operative complication (45.9%), imaging (37.9%) intervention (28.7%) and readmission (29.9%) were significant. The risk profile was vastly heightened compared to that of TLC: intra-operative complications (RR 9.0; p < 0.001), post-operative complications [bile leak (RR 58.9; p < 0.001), collection (RR 12.2; p < 0.001), retained stones (RR 7.2; p < 0.001) and pneumonia (RR 5.4; p < 0.001)], post-operative imaging (RR 4.4; p < 0.001), post-operative intervention (RR 12.3; p < 0.001), prolonged PLOS (RR 11.3; p < 0.001) and readmission (RR 4.5; p < 0.001). The findings were consistent using multivariate logistic regression and propensity analysis.
The relative morbidity associated with SLC is significant and high-risk patients should be counselled for the peri-operative morbidity of subtotal cholecystectomy.
Understanding consent for surgery and for treatment in orthopaedics
Vane Antolič, Marius M. Scarlat
International Orthopaedics, 30 September 2022; 46 pp 2459–2460
Consenting to treatment implies that a person gives permission before receiving any type of medical care, test or examination. The Consent protects the doctor from the accusation of an “unwanted touch”. Surgery is a complex medical act involving treatments, acts, and manoeuvres that could be harmful, although they are expected to be beneficial and amend positively the patient’s health. Prior to obtaining consent for the proposed succession of acts, the surgeon must provide the patient with information about the nature of the treatment, the expected benefits, material risks and adverse effects, alternate treatments, and the consequences of not having the surgery. Consent for surgery has become a critical component of surgical practice and is of increasing importance and must be updated with patient and legal expectations. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The principle of consent is an important part of medical ethics and international human rights law.
How do patients benefit from consent?
The Bulletin, 30 September 2022; 104(7) pp 364-365
Our legal contributor discusses how gaining consent for treatment, and the importance of discussing all alternatives available to a patient, is vital to maintaining good practice.
Editor’s note: The Bulletin is published by the Royal College of Surgeons of England.
Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales
Cynthia A Ochieng, Hollie Richards, Jesmond Zahra, Sian Cousins, Daisy Elliott, Nicholas Wilson, Sangeetha Paramasivan, Kerry N L Avery, Johnny Mathews, Barry G Main, Robert Hinchliffe, Natalie S Blencowe, Jane M Blazeby
BMJ Open, 1 September 2022
To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).
A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
NHS trusts in England and health boards in Wales, UK.
Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.
From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.
Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.